Monday, December 21, 2015

Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products - Questions and Answers

Questions and Answers for Potential Blood Donors and Blood Recipients

Why has FDA revised its recommendations?

The FDA has revisited its donor deferral recommendations to reduce the risk of transmitting human immunodeficiency virus (HIV) several times over the past 10 years. These reviews have been undertaken publicly at meetings of the FDA Blood Products Advisory Committee and the HHS Advisory Committee for Blood Safety and Availability (ACBSA). In 2010, the ACBSA found that the deferral policy for men who have had sex with other men (MSM) was suboptimal and it recommended that studies be conducted to better inform a potential policy change. Once the studies were completed in 2014, the FDA along with other Public Health Service agencies, including the Centers for Disease Control and Prevention, Health Resources and Services Administration, National Institutes of Health, and the Office of the Assistant Secretary for Health, assessed the results of the studies. In November 2014, these results were presented to the HHS Advisory Committee for Blood and Tissue Safety and Availability (the committee that succeeded the ACBSA), which, after considering the results, recommended that a shorter deferral period was appropriate.

What changes have been made to FDA's recommendations?

Prior to the current guidance, FDA’s recommendations were outlined in the April 1992 memorandum, “Revised Recommendations for the Prevention of Human Immunodeficiency Virus (HIV) Transmission by Blood and Blood Products.” Based on the evidence now available, FDA has changed its recommendation from the indefinite deferral for MSM to a 12 month blood donor deferral since last MSM contact. For other behavioral deferrals such as commercial sex workers and injection drug use, insufficient data are available to support a change to the existing deferral recommendations at this time.

FDA is also changing its deferral recommendation rationale for those who have hemophilia or related clotting disorders. Due to the enhanced safety measures now used in the manufacture of clotting factor concentrates, FDA no longer considers those products a risk for HIV. The rationale for deferral of individuals with hemophilia or related clotting factor disorders has changed from preventing HIV transmission to ensuring that such donors are not harmed by the use of large bore needles during the blood donation process. Additionally, the Agency is no longer recommending deferral for individuals who have had sex with someone who has used clotting factor concentrates.

Defer indefinitely an individual who has ever had a positive test for HIV.

Defer indefinitely an individual who has ever exchanged sex for money or drugs.

Defer indefinitely an individual who has ever engaged in injection drug use that was not prescribed.

Defer for 12 months from the most recent contact any individual who has a history of sex with a person who: has ever had a positive test for HIV, ever exchanged sex for money or drugs, or ever engaged in non-prescription injection drug use.

Defer for 12 months from the most recent transfusion any individual who has a history of receiving a transfusion of Whole Blood or blood components donated by another person (allogeneic transfusion).

Defer for 12 months from the most recent exposure any individual who has a history of through-the-skin contact with the blood of another individual, such as a needle stick or blood contact with an open wound or mucous membrane.

Defer for 12 months from the most recent tattoo, ear or body piercing. However, individuals who have undergone tattooing within 12 months of donation are eligible to donate if the tattoo was applied by a state regulated entity with sterile needles and non-reused ink. Individuals who have undergone ear or body piercing within 12 months of donation are eligible to donate if the piercing was done using single-use equipment.

Defer for 12 months after completion of treatment any individual with a history of syphilis or gonorrhea or with a history of diagnosis or treatment for syphilis or gonorrhea in the past 12 months.

Defer for 12 months from the most recent contact a man who has had sex with another man during the past 12 months.

Defer for 12 months from the most recent contact a female who has had sex during the past 12 months with a man who has had sex with another man in the past 12 months.

How do the recommendations apply to transgender individuals?

The FDA’s recommendation to blood establishments is that in the context of the donor history questionnaire, male or female gender should be self-identified and self-reported for the purpose of blood donation.Does the guidance contain recommendations for donor education?

FDA recommends in the current guidance that blood establishments educate all potential donors about the risk of HIV transmission by blood and certain behaviors associated with the risk of HIV infection so that donors can self-defer when appropriate.

Did the FDA consider public input before making changes to the recommendations?

In addition to seeking public input at recent FDA and HHS Advisory Committee meetings, the FDA issued a draft guidance of the same title in May 2015 to seek public input on the proposed changes. Over 700 comments were received from individuals or groups. After considering the comments received, FDA made a number of revisions and clarifications. Some of the key revisions included a clarification on the deferral for women who have sex with MSM, a change in the rationale for deferring individuals with hemophilia or related clotting disorders, the addition of a section that more completely explains the scientific rationale for the revised donor deferral policy for MSM, as well as a number of other minor technical corrections and clarifications.

Will blood establishments be required to adopt these new recommendations?

Blood establishments typically revise their existing standard operating procedures regarding donor deferral following issuance of final FDA guidance on the matter. However, establishments may voluntarily elect more stringent donor deferral criteria than those required or recommended by the FDA.

If a blood establishment chooses to implement the recommended changes, the establishment should appropriately modify its donor educational material and donor history questionnaire as outlined in the guidance, including full-length and abbreviated questionnaires. In many cases these changes will follow a standardized format proposed by the blood industry and accepted by the FDA. Licensed blood establishments must report these changes and have them approved by FDA prior to implementing the new policy.

How do the new recommendations impact people who were previously deferred?

Under these new recommendations, blood establishments will be able to requalify individuals deferred under old criteria provided that they meet current donor eligibility criteria. Previously deferred donors will continue to be deferred if they meet any of the current criteria for donor deferral.

How can I be assured that blood products will still be safe after these changes?

FDA expects that the changes made to the recommendations will maintain or improve blood safety with respect to HIV. The change with respect to MSM reflects current scientific evidence, and better aligns the deferral period with the deferral period for other men and women at increased risk for HIV infection.

A similar change regarding MSM was made in Australia, where the epidemiology of HIV is similar to that in the United States, with no observable adverse effect associated with the change to a 12 month deferral that was implemented in 2000.

To help ensure the continued high level of safety of the blood supply, the FDA is implementing a Transfusion Transmissible Infections Monitoring System (TTIMS). TTIMS will provide critical information, along with new and emerging scientific evidence, to help inform future actions that the FDA may take on blood donor policies. The system will monitor a majority of the blood collected in the U.S. for a number of different transfusion-transmitted viral infections, including HIV. TTIMS will collect incidence, prevalence and risk factor data for blood donations and will have a sophisticated laboratory component. This system is being implemented in collaboration with the NIH’s National Heart, Lung and Blood Institute and U.S. blood collection establishments.

Will the FDA consider further changes to the policy in the future?

The FDA will closely monitor the effects of the current changes over the next few years in order to help ensure that blood safety is maintained. At the same time, the FDA will continue to work in this area and review its donor deferral policies to ensure they reflect the most up-to-date scientific knowledge. This process must be data-driven, so the timeframe for future changes is not something that can be predicted. Where can I get more information?